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Oral CF101 and Methotrexate Treatment in Rheumatoid Arthritis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Can-Fite BioPharma
ClinicalTrials.gov Identifier:
NCT00280917
First received: January 23, 2006
Last updated: March 10, 2015
Last verified: June 2011
History of Changes
Results First Received: February 24, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Intervention: Drug: CF101

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
CF101 0.1mg CF101 0.1 mg q12 hours orally
CF101 1mg CF101 1mg q12 hours orally
CF101 4mg CF101 4mg q12 hours orally
Placebo Matching placebo q12 hours orally

Participant Flow:   Overall Study
    CF101 0.1mg     CF101 1mg     CF101 4mg     Placebo  
STARTED     65     63     63     63  
COMPLETED     63     57     57     61  
NOT COMPLETED     2     6     6     2  
Adverse Event                 1                 1                 4                 1  
Change Therapy                 1                 2                 0                 0  
Withdrawal by Subject                 0                 2                 0                 1  
Noncompliance                 0                 1                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
CF101 0.1mg CF101 0.1 mg q12 hours for 12 weeks
CF101 1mg CF101 1 mg q12 hours for 12 weeks
CF101 4mg CF101 4 mg q12 hours for 12 weeks
Placebo Matching Placebo q12 hours for 12 weeks
Total Total of all reporting groups

Baseline Measures
    CF101 0.1mg     CF101 1mg     CF101 4mg     Placebo     Total  
Number of Participants  
[units: participants]
 		  65     63     63     63     254  
Age  
[units: years]
Mean (Standard Deviation) 		  54.7  (12.02)     54.3  (9.98)     54.4  (10.07)     53  (10.86)     54.1  (10.73)  
Gender  
[units: participants]
 		         
Female     49     46     52     52     199  
Male     16     17     11     11     55  



  Outcome Measures

1.  Primary:   ACR Efficacy Criteria   [ Time Frame: 12 weeks ]
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2.  Secondary:   ACR Criteria Components   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Safety   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Pnina Fishman, PhD
Organization: Can-Fite Biopharma
phone: 011972 39241114
e-mail: pnina@canfite.co.il


Publications:


Responsible Party: Can-Fite BioPharma
ClinicalTrials.gov Identifier: NCT00280917     History of Changes
Other Study ID Numbers: CF101-202RA
Study First Received: January 23, 2006
Results First Received: February 24, 2015
Last Updated: March 10, 2015
Health Authority: United States: Food and Drug Administration